{"id":3138,"date":"2013-02-19T21:32:45","date_gmt":"2013-02-19T21:32:45","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3138"},"modified":"2013-02-19T21:32:45","modified_gmt":"2013-02-19T21:32:45","slug":"eu-mdd-aimdd-ivdd-harmonized-standards-en980-en-iso-15223-1-ooopppss","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2013\/02\/19\/eu-mdd-aimdd-ivdd-harmonized-standards-en980-en-iso-15223-1-ooopppss\/","title":{"rendered":"EU MDD, AIMDD, IVDD Harmonized Standards (EN980 & EN ISO 15223-1) Ooopppss!"},"content":{"rendered":"

The EN 980 Symbols for use in the labeling of medical devices<\/em> standard was mistakenly taken off of the EU Harmonized List of standards on the Jan 24, \u201913 release and EN ISO 15223-1 Medical devices — Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: General requirements<\/em>\u00a0was anticipated to be Harmonized but it wasn’t Harmonized under the MDD, AIMDD, or IVDD.\u00a0 <\/span><\/p>\n

The EU Commission has advised that the disappearance of EN 980 was a mistake and it is still Harmonized and will be corrected at the next release of the updated Harmonized Standards Listing, hopefully in the next few months. \u00a0 The EU Commission didn’t Harmonize the EN ISO 15223-1 because they saw issues in relation to the Directives (MDD, AIMDD, & IVDD) and Annex Z’s (e.g. Annex ZA, ZB, ZC) of the standard EN ISO 15223-1:2012.\u00a0 Because the standard EN ISO 15223-1 wasn\u2019t Harmonized under this last round by the EU Commission CEN extended the date of withdrawal of EN ISO 15223-1:2012 from Jan 31, \u201813 to Jul 1, \u201915.<\/span><\/p>\n

For access to the current list of Harmonized Standards, published Jan 24, ’13, they are available thru our previous post FDA & EU MDD \/ AIMDD \/ IVDD Updated Standards Lists<\/a><\/strong>.<\/span><\/span><\/p>\n

Christine Ruther, an Eisner Safety Consultants Associate reminded us<\/span><\/p>\n

\u201cThe directives already allows the use of symbols from non-harmonized standards with the stipulation that the symbols and colours must be described in the documentation supplied with the device (e.g., MDD Annex I item 13.2).\u00a0 As most manufacturers define all symbols, regardless of origin, this gap in a harmonized standard for symbols should not be an issue.<\/span><\/p>\n

In any event, manufacturers are expected to take a common sense approach to managing the situation.\u00a0 This will likely entail writing a short quality plan that acknowledges the situation and defines what actions will be taken.\u00a0 Actions might include waiting for the next update of harmonized standards to confirm which standards are harmonized, reviewing existing use of symbols to confirm compliance with EN ISO 15223-1 in anticipation of the change, or other actions.\u201d \u00a0NOTE: It is not clear, at this point, if the EU Commission will Harmonize EN ISO 15223-1:2012 for the next publication of the List of Harmonized Standards for the MDD, AIMDD, & IVDD.<\/span><\/p>\n

For Christine\u2019s part of this post we should also thank NSAI for forwarding information on this momentary vacuum.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

The EN 980 Symbols for use in the labeling of medical devices standard was mistakenly taken off of the EU Harmonized List of standards on the Jan 24, \u201913 release and EN ISO 15223-1 Medical devices — Symbols to be<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[262,35,36,908,909,910,27,185,186,884,206,911,20,37,912,255,12,28,330,266,174,175,149,913,914],"class_list":["post-3138","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-active-implantable-medical-devices-directive","tag-aimdd","tag-cenelec","tag-en-980","tag-en-iso-15223-1","tag-en-iso-15223-12012","tag-escnews","tag-eu","tag-eu-commission","tag-eu-harmonized-standards","tag-european-commission","tag-iso-15223-1","tag-ivd","tag-labeling","tag-labels","tag-list-of-harmonized-standards","tag-mdd","tag-mdd-amendment","tag-medical-device","tag-medical-device-directive","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-devices","tag-symbol","tag-symbols"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3138","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=3138"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3138\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=3138"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=3138"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=3138"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}